Clinical Research Directory

A Study to Learn How Different Amounts of the Study Medicine Called PF-08161842 Are Tolerated and Act in the Body in Healthy and Older Adults

Sponsor: Pfizer

Summary

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called PF-08161842) and how it is processed by the body. This is the first time PF-08161842 will be given to people. This study is seeking healthy adults: * 18 to 64 years of age or 65 to 85 years of age * Who are in generally good health * Who meet study conditions for body weight and body mass index (BMI) Participants will receive either PF-08161842 tablets or matching placebo tablets. Placebo tablets do not contain active medicine. In some study groups, participants will receive a single dose of study medicine. In other study groups, they will receive the study medicine for 14 days. The tablets will be taken by mouth at the study clinic. The investigators will compare the experiences of people receiving the study medicine with those of people who do not. This will help researchers determine if PF-08161842 is safe and how it affects the body. Participants will stay at the study clinic for several days so the study team can closely monitor their health. The study will include physical examinations, checks of blood pressure, heart rate, temperature, and breathing. It will also include blood and urine samples and heart tracing tests (ECGs). Researchers will assess how the body processes the study medicine. Some participants will also have lumbar punctures (spinal taps) to collect small samples of fluid from around the brain and spinal cord. The study team will monitor participants for any reactions throughout the study. For people receiving a single dose, the study will last for about 9 weeks. For those receiving multiple doses the study will last for about 11 weeks. This includes screening, study visits, clinic stay, and follow-up contact after the last dose.

Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE AND MULTIPLE ORAL DOSES OF PF-08161842 IN HEALTHY AND OLDER PARTICIPANTS

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